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Study Ref. Design studied treatmentcontrol treatmentpatientsstudy risk of biassample sizes Results

COVID-19 prophylaxis (excluding children) meta-analysis

Asano
 
NCT04568031
RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)placeboCOVID-19 prophylaxis (excluding children)NA
-/- inconclusive
    Com-COV2
     
    ISRCTN 27841311
    RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)vaccinesCOVID-19 prophylaxis (excluding children)NA
    -/- inconclusive
      Li J
       
      NCT04892459
      RCTCanSino (Convidecia)CoronaVac (SinoVac)COVID-19 prophylaxis (excluding children)NA
      147/152 inconclusive
        No thromboses, vaccine-related anaphylaxis or other serious adverse events were observed in any of the groups by day 28 after the booster
        AstraZeneca phase 3 US (D8110C00001)
         
        NCT04516746
        RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)placeboCOVID-19 prophylaxis (excluding children)NA
        21583/10796 safety concern
        • suggested 76 % decrease in symptomatic Covid-19
        • statistically significant 62 % increase in adverse events
        statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization. In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9%
        Com-COV
         
        ISRCTN69254139
        RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
        -/- inconclusive
          Fengcai
           
          NCT04566770
          RCTCanSino (Convidecia)placeboCOVID-19 prophylaxis (excluding children)NA
          320/110 safety concern
          • statistically significant 19.2-fold increase in systemic adverse reaction, any, dose 1
          • statistically significant 3.4-fold increase in systemic adverse reaction, any, dose 2
          Kulkarni
           
          CTRI/2020/08/027170
          RCTCovishield (Oxford/AZ formulation)placeboCOVID-19 prophylaxis (excluding children)NA
          1200/300 inconclusive
            There were no thromboembolic-associated or autoimmune-related SAEs
            Reindl-Schwaighofer RCTJanssen AD26 vaccine (JNJ-78436735)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
            100/101 inconclusive
              Sadoff
               
              NCT04436276
              RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)NA
              -/- inconclusive
                Interim Results of a Phase 1–2a Trial : cohort 1 (healthy adults 18-55y) and 3 (>65y). Data that are reported here were collected after the administration of the second dose (either vaccine or placebo) in cohort 1a and after the first dose in cohort 3
                AstraZeneca Oxford pooled analysis (COV003, COV001, COV002, COV005)_safety RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                12282/11962 inconclusive
                  pooled data of four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), andNCT04444674 (COV005)
                  CanSino phase 2 (Zhu)
                   
                  NCT04341389
                  RCTCanSino (Convidecia)placeboCOVID-19 prophylaxis (excluding children)NA
                  382/126 inconclusive
                    No serious adverse events were documented within 28 days
                    ChAdOx1 phase 3 (AstraZeneca)
                     
                    NCT04400838
                    RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)some concern
                    5807/5829 conclusif
                    • demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
                    RESIST (Sputnik V Gamaleya Research Institute Russia)
                     
                    NCT04530396
                    RCTSputnik V (Gam-COVID-Vac)placeboCOVID-19 prophylaxis (excluding children)high
                    16501/5476 suggested
                    • suggested 73 % decrease in confirmed Covid-19, from 1st dose but with a low degree of certainty due to high risk of bias
                    • suggested 92 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                    ENSEMBLE (COV3001) unpublished
                     
                    NCT04505722
                    RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)some concern
                    21895/21888 conclusif
                    • suggested 81 % decrease in deaths with a moderate degree of certainty due to some concern in risk of bias
                    • demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
                    • suggested 82 % decrease in hospitalization with a moderate degree of certainty due to some concern in risk of bias
                    MixNMatch Study
                     
                    NCT04889209
                    OBSJanssen AD26 vaccine (JNJ-78436735)mRNA vaccineCOVID-19 prophylaxis (excluding children)NA
                    -/- inconclusive
                      Scotland cohort unpublished OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                      -/- suggested
                        Botton (EPI-PHARE) OBSJanssen AD26 vaccine (JNJ-78436735)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
                        -/- safety concern
                        • statistically significant 5.7-fold increase in hospitalization
                        EPIPHARE (Janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
                        -/- safety concern
                        • statistically significant 75 % increase in Myocardial infarction
                        EPIPHARE (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                        -/- safety concern
                        • statistically significant 29 % increase in Myocardial infarction
                        • statistically significant 41 % increase in pulmonary embolism
                        Hippisley-Cox OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                        -/- safety concern
                        • statistically significant 10 % increase in venous thromboembolism
                        Husby (janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
                        -/- inconclusive
                          Patone OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                          -/- safety concern
                          • statistically significant 1.3-fold increase in Guillain-Barré syndrome
                          • statistically significant 1.0-fold increase in Guillain-Barré syndrome
                          Simpson (ChAdOx1) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                          -/- safety concern
                          • statistically significant 98 % increase in immune thrombocytopenia
                          Nabirova OBSSputnik V (Gam-COVID-Vac)controlCOVID-19 prophylaxis (excluding children)NA
                          -/- suggested
                          • suggested 77 % decrease in new illness compatible with Covid-19
                          Bernal (PHE, 19th February 2021) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                          -/- no results
                            Burn (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
                            -/- safety concern
                            • statistically significant 1.0-fold increase in immune thrombocytopenia but with a very low degree of certainty due to critical risk of bias
                            • statistically significant 23 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias
                            • statistically significant 25 % increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias
                            Edward (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
                            -/- inconclusive
                              Bernal unpublished OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                              -/- suggested
                              • suggested 55 % decrease in deaths,deaths
                              Pottegard OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
                              -/- safety concern
                              • statistically significant 1.3-fold increase in intracranial hemorrhage but with a very low degree of certainty due to critical risk of bias
                              • statistically significant 79 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias
                              • statistically significant 2.0-fold increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias
                              • statistically significant 97 % increase in venous thromboembolism but with a very low degree of certainty due to critical risk of bias
                              • statistically significant 19.3-fold increase in cerebral venous sinus thrombosis (CVST) but with a very low degree of certainty due to critical risk of bias

                              PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
                              Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).